Eligibility Leukemia NCT01191801

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StudyEvent: Eligibility
1. Eligibility Leukemia NCT01191801

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed Consent

Item

provide signed, written informed consent

boolean

C0021430 (UMLS CUI [1])

Age

Item

are at least 18 years of age

boolean

C0001779 (UMLS CUI [1])

AML WHO classification

Item

have a diagnosis of aml according to world health organization (who) classification

boolean

C0023467 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])

AML First Relapse | AML Unresponsive to Induction Therapy

Item

first relapsed or refractory aml (refractory to initial induction therapy)

boolean

C0023467 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])

ECOG performance status

Item

have an ecog score of 0-2

boolean

C1520224 (UMLS CUI [1])

Liver function | Renal function | Laboratory Results

Item

have adequate liver and renal function as indicated by certain laboratory values

boolean

C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1254595 (UMLS CUI [3])

Fertility Absent | Use of Contraceptive methods

Item

are nonfertile or agree to use an adequate method of contraception until 30 days after the last treatment

boolean

C0015895 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Induction Therapy Quantity AML

Item

have received more than 2 cycles of induction therapy for aml

boolean

C0600558 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])

Unresponsive to Treatment | Recurrent disease | Status post IDAC protocol | Status post Cytarabine High dose

Item

refractory to or relapsed within the previous 3 months after therapy with an idac- or hidac-containing regimen

boolean

C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1173669 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0010711 (UMLS CUI [4,2])
C0444956 (UMLS CUI [4,3])

Hemopoietic stem cell transplant

Item

have received a hematopoietic stem cell transplant (hsct) within the previous 3 months

boolean

C0472699 (UMLS CUI [1])

Therapeutic immunosuppression Graft-vs-Host Disease

Item

have received active immunosuppressive therapy for graft-versus-host disease (gvhd) within 2 weeks before study start

boolean

C0021079 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])

Item

have any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system

boolean

C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0460002 (UMLS CUI [6,2])

Central Nervous System Involvement AML

Item

have evidence of central nervous system involvement of active aml

boolean

C4050309 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])

Cancer Other | Exception Skin carcinoma | Exception Cervical Intraepithelial Neoplasia | Hematologic Neoplasms

Item

have other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0206708 (UMLS CUI [3,2])
C0376545 (UMLS CUI [4])

Communicable Disease Uncontrolled

Item

have an active, uncontrolled infection

boolean

C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])

Therapy, Investigational

Item

are receiving any other investigational therapy

boolean

C0949266 (UMLS CUI [1])

vosaroxin

Item

have received previous treatment with vosaroxin

boolean

C1451341 (UMLS CUI [1])

Pregnancy | Breast Feeding

Item

are pregnant or lactating

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Other medical condition Interferes with Informed Consent | Other medical condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Follow-up | Mental condition Interferes with Informed Consent | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Follow-up | Social situation Interferes with Informed Consent | Social situation Interferes with Study Subject Participation Status | Social situation Interferes with Follow-up

Item

have any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up

boolean

C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C3274571 (UMLS CUI [9,3])

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Eligibility Leukemia NCT01191801